Label: CAREONE ALLERGY RELIEF- cetirizine hydrochloride capsule, liquid filled

  • NDC Code(s): 41520-715-63
  • Packager: American Sales Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated August 16, 2021

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  • Active ingredient (in each capsule)

    Cetirizine HCl 10 mg

  • Purpose

    Antihistamine

  • Uses

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    •
    runny nose
    •
    sneezing
    •
    itchy, watery eyes
    •
    itching of the nose or throat
  • Warnings

    Do not use

    if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine.

    Ask a doctor before use if you have

    liver or kidney disease. Your doctor should determine if you need a different dose.

    Ask a doctor or pharmacist before use if you are

    taking tranquilizers or sedatives.

    When using this product

    •
    drowsiness may occur
    •
    avoid alcoholic drinks
    •
    alcohol, sedatives, and tranquilizers may increase drowsiness
    •
    be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    an allergic reaction to this product occurs. Seek medical help right away.

    If pregnant or breast-feeding:

    •
    if breast-feeding: not recommended
    •
    if pregnant: ask a health professional before use.

    Keep out of reach of children.

    In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • Directions

    adults and children 6 years and over

    one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

    adults 65 years and over

    ask a doctor

    children under 6 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor
  • Other information

    •
    store between 20-25°C (68-77°F)
    •
    avoid high humidity and excessive heat above 40°C (104°F)
    •
    protect from light
    •
    do not use if printed foil under cap is broken or missing
  • Inactive ingredients

    butylated hydroxytoluene, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol 400, purified water, sodium hydroxide, sorbitan, sorbitol

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to the active ingredient in Zyrtec® Liquid Gels

    24hr

    ORIGINAL PRESCRIPTION STRENGTH

    Allergy Relief

    Cetirizine Hydrochloride Capsules, 10mg

    Antihistamine

    25 LIQUID GELS**

    Actual Size

    **Liquid Filled Capsules

    INDOOR & OUTDOOR ALLERGIES

    24 HOUR RELIEF OF:

    - Sneezing

    - Runny Nose

    - Itchy, Watery Eyes

    - Itchy Throat or Nose

    OUR PHARMACISTS RECOMMEND

    Allergy Relief Carton
  • INGREDIENTS AND APPEARANCE
    CAREONE ALLERGY RELIEF 
    cetirizine hydrochloride capsule, liquid filled
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-715
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    ColorYELLOWScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code 10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-715-631 in 1 CARTON08/03/2021
    125 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20723508/03/2021
    Labeler - American Sales Company (809183973)
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